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United States · US · US:42799-405_3567b92a-d07e-435b-b7fb-583d29fd0785

Ethacrynic Acid

Orange BookUNIISPLATC C03CC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeC03CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4279940501
    100 TABLET in 1 BOTTLE (42799-405-01)

Annotations

UNII (FDA Substance ID)
M5DP350VZV
ETHACRYNIC ACID
RxCUI 4109
Orange Book
A205609
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M5DP350VZV",
    "rxcui": "4109",
    "inchikey": "AVOLMBLBETYQHX-UHFFFAOYSA-N",
    "display_name": "ETHACRYNIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b9bc3907-bfa7-4d9f-90d9-c2097230f7e4": {
      "match": "brand_token",
      "title": "ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "6",
      "published_date": "2026-04-27"
    }
  },
  "productid": "42799-405_3567b92a-d07e-435b-b7fb-583d29fd0785",
  "productndc": "42799-405",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jun 30, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHACRYNIC ACID",
  "proprietary_name": "Ethacrynic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ethacrynic Acid",
  "start_marketing_date": "20160701",
  "active_numerator_strength": "25"
}

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